Severe Acute PancreatitisNCT07816900
Efficacy and Safety of Da-Cheng-Qi Decoction in Severe Acute Pancreatitis
A study testing Da-Cheng-Qi Decoction Plus Standard Western Treatment and Standard Western Treatment in people with Severe Acute Pancreatitis and Intra-abdominal Hypertension, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This single-center prospective randomized controlled trial evaluated Da-Cheng-Qi Decoction (DCQD) as the acute-stage intervention of an integrated traditional Chinese and Western medicine whole-stage treatment protocol for severe acute pancreatitis (SAP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Acute Pancreatitis, Intra-abdominal Hypertension
- What is being tested?
- Da-Cheng-Qi Decoction Plus Standard Western Treatment and Standard Western Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 25 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe acute pancreatitis diagnosed according to the revised Atlanta classification
- Age 18-80 years
- Disease onset within 72 h
- Intra-abdominal hypertension (IAP >= 12 mmHg) within 24 h of admission
- Written informed consent obtained
Who cannot join
- Age <18 or >80 years
- Pregnancy or lactation
- Advanced malignancy (pancreatic, hepatobiliary, or gastrointestinal)
- Severe chronic organ failure
- Autoimmune disease or immunosuppression
- Intra-abdominal hemorrhage
Show all 9Show fewer
- Urinary tract infection or prior bladder surgery (precluding bladder manometry)
- Allergic constitution or known allergy to study medication
- Psychiatric illness
Trial locations and contacts
1 site in 1 country.
China1 site
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: Efficacy and Safety of Da-Cheng-Qi Decoction in the Acute Stage of Severe Acute Pancreatitis: a Single-Center, Prospective, Randomized, Controlled Trial
This single-center prospective randomized controlled trial evaluated Da-Cheng-Qi Decoction (DCQD) as the acute-stage intervention of an integrated traditional Chinese and Western medicine whole-stage treatment protocol for severe acute pancreatitis (SAP). Sixty adults with SAP and intra-abdominal hypertension (IAP ≥ 12 mmHg) were randomized within 72 h of onset to receive standard Western treatment plus DCQD (100 mL via nasogastric tube twice daily for 7 days) or standard Western treatment alone. The primary outcome was intra-abdominal pressure measured by standardized bladder manometry every 12 h for 7 days. Secondary outcomes included stool output, length of hospital and ICU stay, and 28-day mortality. The trial was conducted at the Emergency Intensive Care Unit of Ruijin Hospital between April 2026 and July 2026.
Read the detailed description
Rationale: DCQD, recorded in the Shang Han Lun, is a classical purgative formula. This trial is the acute-stage component of the "Integrated Traditional Chinese and Western Medicine Whole-Stage Treatment Protocol for SAP" (parent study, 200 participants; Medical Research Filing No. MR-31-26-073582; ethics approval 2026-178; funding: Bureau-level project 2026150).
Why only the acute stage was randomized: DCQD is administered during the acute stage (within 72 h of onset), the stage at which prospective randomization is both feasible and scientifically meaningful. Once patients enter the infection stage (Huang-Qin Decoction combined with Du-Shen Decoction) and recovery stage (Si-Jun-Zi Decoction combined with Ban-Xia-Xie-Xin Decoction), allocation has been determined by the acute-stage randomization and the acute-stage intervention has already been administered; separate prospective trials for these stages would be neither feasible nor scientifically meaningful. No independent protocols exist for the later stages; their data are collected within the parent protocol.
Final attribution: Follow-up data from these 60 participants will be fully incorporated into the parent cohort (n = 200) for final analysis. This registration covers the acute-stage randomized comparison of DCQD versus standard Western treatment alone.
DCQD composition: Rheum palmatum L. (15 g, added later), processed Magnolia officinalis (12 g), honey-bran-fried Citrus aurantium L. (15 g), and mirabilite (15 g), prescribed by TCM physicians on the basis of syndrome differentiation and prepared by the Department of Traditional Chinese Medicine.
- Being tested
- Da-Cheng-Qi Decoction Plus Standard Western Treatment, Standard Western Treatment
- Keywords
- Da-Cheng-Qi Decoction, traditional Chinese medicine, intra-abdominal pressure, paralytic ileus
- Medical subject headings
- Pancreatitis, Intra-Abdominal Hypertension, Intestinal Pseudo-Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Da-Cheng-Qi Decoction Plus Standard Western TreatmentDrug
Participants in this arm receive standard Western treatment for severe acute pancreatitis (acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and circulatory, respiratory, and nutritional support) PLUS Da-Cheng-Qi Decoction, a classical purgative herbal formula comprising Rheum palmatum L. (15 g, added later), processed Magnolia officinalis (12 g), honey-bran-fried Citrus aurantium L. (15 g), and mirabilite (15 g), prescribed by TCM physicians on the basis of syndrome differentiation and prepared by the Department of Traditional Chinese Medicine. DCQD granules are dissolved in 100 mL warm water and administered via nasogastric tube twice daily for 7 days during the acute stage.
Standard Western TreatmentOther
Standard management of severe acute pancreatitis: acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and organ support including circulatory, respiratory, and nutritional support, plus control granules containing one-tenth of the DCQD dose, matching the aroma, appearance, and taste of the full-dose formulation. The control granules are dissolved in 100 mL warm water and administered via nasogastric tube twice daily for 7 days, in identical opaque packaging, so that participants remain blinded to group assignment.
| Study group | Role | What they receive |
|---|---|---|
| DCQD Plus Standard Western Treatment | Experimental | The acute-stage component of the integrated Chinese-Western whole-stage protocol. Standard Western treatment for severe acute pancreatitis (acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, organ support) PLUS DCQD granules dissolved in 100 mL warm water via nasogastric tube twice daily for 7 days. Receives: Drug: Da-Cheng-Qi Decoction Plus Standard Western Treatment |
| Standard Western Treatment | Active comparator | Standard Western treatment for severe acute pancreatitis, including acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and organ support (circulatory, respiratory, nutritional), PLUS control granules containing one-tenth of the DCQD dose, dissolved in 100 mL warm water via nasogastric tube twice daily for 7 days, in identical opaque packaging (participant-blinded). Receives: Other: Standard Western Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intra-abdominal Pressure
Intra-abdominal pressure measured by standardized bladder manometry at baseline and every 12 h for 7 days
Measured: From baseline before the first dose through Day 7, assessed every 12 hours after randomization
Secondary outcomes (5)
Stool Output
Cumulative stool volume per 24-hour interval.
Measured: Day 1 through Day 7
Length of Hospital Stay
Duration of hospitalization from admission to discharge
Measured: From randomization to hospital discharge or through study completion, an average of 33 days
Length of ICU Stay
Duration of intensive care unit stay.
Measured: From randomization to intensive care unit discharge, up to 28 days
28-Day Mortality
All-cause mortality within 28 days of randomization.
Measured: 28 days
Adverse Events
Incidence and severity of adverse events during treatment and follow-up.
Measured: From randomization to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Apr 2026
- Primary completion5 Jul 2026
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Ma, Ruijin Hospital
- Investigators
- Enqiang Mao, MD, PhD, Study chair, Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816900
- Sponsor's protocol ID
- MR-31-26-073582
- Other IDs
- 2026-178, 2026150
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Da-Cheng-Qi Decoction in the Acute Stage of Severe Acute Pancreatitis: a Single-Center, Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07816900
- Acronym / sponsor ID
- MR-31-26-073582
- Keywords
- Da-Cheng-Qi Decoction, traditional Chinese medicine, intra-abdominal pressure, paralytic ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 5 Jul 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center prospective randomized controlled trial evaluated Da-Cheng-Qi Decoction (DCQD) as the acute-stage intervention of an integrated traditional Chinese and Western medicine whole-stage treatment protocol for severe acute pancreatitis (SAP). Sixty adults with SAP and intra-abdominal hypertension (IAP ≥ 12 mmHg) were randomized within 72 h of onset to receive standard Western treatment plus DCQD (100 mL via nasogastric tube twice daily for 7 days) or standard Western treatment alone. The primary outcome was intra-abdominal pressure measured by standardized bladder manometry every 12 h for 7 days. Secondary outcomes included stool output, length of hospital and ICU stay, and 28-day mortality. The trial was conducted at the Emergency Intensive Care Unit of Ruijin Hospital between April 2026 and July 2026.
Detailed description
Rationale: DCQD, recorded in the Shang Han Lun, is a classical purgative formula. This trial is the acute-stage component of the "Integrated Traditional Chinese and Western Medicine Whole-Stage Treatment Protocol for SAP" (parent study, 200 participants; Medical Research Filing No. MR-31-26-073582; ethics approval 2026-178; funding: Bureau-level project 2026150).
Why only the acute stage was randomized: DCQD is administered during the acute stage (within 72 h of onset), the stage at which prospective randomization is both feasible and scientifically meaningful. Once patients enter the infection stage (Huang-Qin Decoction combined with Du-Shen Decoction) and recovery stage (Si-Jun-Zi Decoction combined with Ban-Xia-Xie-Xin Decoction), allocation has been determined by the acute-stage randomization and the acute-stage intervention has already been administered; separate prospective trials for these stages would be neither feasible nor scientifically meaningful. No independent protocols exist for the later stages; their data are collected within the parent protocol.
Final attribution: Follow-up data from these 60 participants will be fully incorporated into the parent cohort (n = 200) for final analysis. This registration covers the acute-stage randomized comparison of DCQD versus standard Western treatment alone.
DCQD composition: Rheum palmatum L. (15 g, added later), processed Magnolia officinalis (12 g), honey-bran-fried Citrus aurantium L. (15 g), and mirabilite (15 g), prescribed by TCM physicians on the basis of syndrome differentiation and prepared by the Department of Traditional Chinese Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCQD Plus Standard Western Treatment | Experimental | Drug: Da-Cheng-Qi Decoction Plus Standard Western TreatmentThe acute-stage component of the integrated Chinese-Western whole-stage protocol. Standard Western treatment for severe acute pancreatitis (acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, organ support) PLUS DCQD granules dissolved in 100 mL warm water via nasogastric tube twice daily for 7 days. |
| Standard Western Treatment | Active comparator | Other: Standard Western TreatmentStandard Western treatment for severe acute pancreatitis, including acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and organ support (circulatory, respiratory, nutritional), PLUS control granules containing one-tenth of the DCQD dose, dissolved in 100 mL warm water via nasogastric tube twice daily for 7 days, in identical opaque packaging (participant-blinded). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe acute pancreatitis diagnosed according to the revised Atlanta classification
- Age 18-80 years
- Disease onset within 72 h
- Intra-abdominal hypertension (IAP >= 12 mmHg) within 24 h of admission
- Written informed consent obtained
Key exclusion criteria (9 listed)
- Age <18 or >80 years
- Pregnancy or lactation
- Advanced malignancy (pancreatic, hepatobiliary, or gastrointestinal)
- Severe chronic organ failure
- Autoimmune disease or immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Da-Cheng-Qi Decoction Plus Standard Western TreatmentParticipants in this arm receive standard Western treatment for severe acute pancreatitis (acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and circulatory, respiratory, and nutritional support) PLUS Da-Cheng-Qi Decoction, a classical purgative herbal formula comprising Rheum palmatum L. (15 g, added later), processed Magnolia officinalis (12 g), honey-bran-fried Citrus aurantium L. (15 g), and mirabilite (15 g), prescribed by TCM physicians on the basis of syndrome differentiation and prepared by the Department of Traditional Chinese Medicine. DCQD granules are dissolved in 100 mL warm water and administered via nasogastric tube twice daily for 7 days during the acute stage. | Drug | DCQD Plus Standard Western Treatment |
| Standard Western TreatmentStandard management of severe acute pancreatitis: acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and organ support including circulatory, respiratory, and nutritional support, plus control granules containing one-tenth of the DCQD dose, matching the aroma, appearance, and taste of the full-dose formulation. The control granules are dissolved in 100 mL warm water and administered via nasogastric tube twice daily for 7 days, in identical opaque packaging, so that participants remain blinded to group assignment. | Other | Standard Western Treatment |
Primary outcome
Change in Intra-abdominal Pressure
Time frame: From baseline before the first dose through Day 7, assessed every 12 hours after randomization
Intra-abdominal pressure measured by standardized bladder manometry at baseline and every 12 h for 7 days
5 secondary outcomes
Stool Output
Time frame: Day 1 through Day 7
Length of Hospital Stay
Time frame: From randomization to hospital discharge or through study completion, an average of 33 days
Length of ICU Stay
Time frame: From randomization to intensive care unit discharge, up to 28 days
28-Day Mortality
Time frame: 28 days
Adverse Events
Time frame: From randomization to day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Severe Acute Pancreatitis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
RecruitingPhase 2
Study of SGC001 Injection for Predicted Severe Acute Pancreatitis to Assess Safety, Tolerability and Preliminary Efficacy
Acute Pancreatitis
RecruitingPhase 3
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Severe Hypertriglyceridemia
Active, not recruitingPhase 2
Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis
Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
Acute Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enqiang Mao, MD, PhD study chair
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Da-Cheng-Qi Decoction Plus Standard Western Treatment and Standard Western Treatment in people with Severe Acute Pancreatitis and Intra-abdominal Hypertension, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intra-abdominal Pressure (time frame: From baseline before the first dose through Day 7, assessed every 12 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.